Exercise Intervention to Support Recovery After Allogeneic Stem Cell Transplantation in Adults With Myeloid Blood Disorders

NCT07868653 | Not Yet Recruiting

• 1 other identifier: 26-13152-BO
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn how a 12-week exercise intervention affects recovery after allogeneic stem cell transplantation in adults with a myeloid blood disorder. The main question is whether the exercise intervention helps maintain or improve thinking skills, especially attention, mental flexibility, and working memory, compared with usual care. The study will also look at physical function, quality of life, symptoms, activity levels, and clinical recovery. After leaving the hospital following stem cell transplantation, participants will be randomly assigned to one of two groups. One group will receive the 12-week exercise intervention in addition to usual care. The other group will receive usual care without an additional RESTART exercise program during these 12 weeks. Participants in the exercise group will complete three exercise sessions each week: one individual in-person session, one guided online session, and one home-based session. The exercises may include endurance, strength, mobility, balance, coordination, and activities that combine movement with thinking tasks. The program will be adjusted to each participant's health, fitness, symptoms, and daily condition. All participants will complete study assessments shortly before transplantation, at hospital discharge, and after the 12-week intervention or control period. Follow-up assessments will also take place 6 and 12 months after discharge, mainly using questionnaires and clinical information from routine care.

Conditions

Myeloid Malignancies

Keywords

Allogeneic Hematopoietic Stem Cell Transplantation; Myeloid Malignancies; Exercise Intervention; Exercise Therapy; Exercise Oncology; Executive Function; Cognitive Function; Physical Performance; Quality of Life; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Executive Function Composite Score From Hospital Discharge to 13 Weeks After Discharge

  Executive function is assessed using a standardized composite score derived from performance on the Flanker Task (reaction time, error rate, and flanker effect), Trail Making Test Part B (completion time), and Digit Span Backward (score). Individual test measures are standardized and combined into a composite score representing executive function, including inhibitory control, cognitive flexibility, and working memory. Test measures are transformed as needed so that higher composite scores indicate better executive function.

  Hospital discharge (T1) and 13 weeks after hospital discharge, following the 12-week intervention or control period (T2)

Secondary Outcomes (21)

• Change in Global Cognitive Function Assessed by the Montreal Cognitive Assessment (MoCA)

  Pre-HSCT (T0), hospital discharge (T1), and 13 weeks after hospital discharge (T2)

• Change in Reaction Time Assessed by the OORTT 4 Positions Reaction Times

  Hospital discharge (T1) and 13 weeks after hospital discharge (T2)

• Change in Inhibitory Control Assessed by the Flanker Task

  Pre-HSCT (T0), hospital discharge (T1), and 13 weeks after hospital discharge (T2)

• Change in Cognitive Flexibility Assessed by Trail Making Test Part B

  Hospital discharge (T1) and 13 weeks after hospital discharge (T2)

• Change in Working Memory Assessed by Digit Span Backward

  Hospital discharge (T1) and 13 weeks after hospital discharge (T2)

Other Outcomes (15)

• Change in White Blood Cell Count

  Pre-HSCT (T0) through 12 months after hospital discharge (T4), as available from routine clinical care

• Change in Absolute Neutrophil Count

  Pre-HSCT (T0) through 12 months after hospital discharge (T4), as available from routine clinical care

• Change in Absolute Lymphocyte Count

  Pre-HSCT (T0) through 12 months after hospital discharge (T4), as available from routine clinical care

Study Arms (2)

Exercise Intervention Group

EXPERIMENTAL

Participants assigned to this arm receive the 12-week RESTART exercise intervention in addition to usual medical, nursing, and supportive care after allogeneic hematopoietic stem cell transplantation.

Behavioral: Multimodal Exercise Intervention

Usual Care Control Group

NO INTERVENTION

Participants assigned to this arm receive usual medical, nursing, and supportive care during the 12-week control period. No additional RESTART exercise intervention is provided during this period. Medically indicated care and self-directed physical activity are not restricted.

Interventions

Multimodal Exercise Intervention BEHAVIORAL

Participants receive a 12-week individualized, multimodal exercise intervention in addition to usual care, consisting of three sessions per week: one individual in-person session (approximately 60 minutes), one live supervised online session (approximately 45 minutes), and one independently performed home-based session (approximately 30 minutes). Across the intervention, exercise content may include aerobic, resistance, mobility, balance, coordination, and cognitive-motor exercises. Training duration, intensity, exercise selection, and volume are individually adapted to the participant's medical condition, physical capacity, treatment-related symptoms, daily condition, and personal goals. In-person and online sessions are supervised by qualified exercise therapists; home-based exercises are individually selected and explained in advance, with an emphasis on low-risk, easily controllable exercises that can be performed safely without direct supervision.

Exercise Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Scheduled to undergo a first allogeneic hematopoietic stem cell transplantation (HSCT) with an inpatient hospital stay for a myeloid blood disorder
• Cleared by the treating physician to participate in physical exercise before and after HSCT
• Able to move around independently or with the use of an assistive device
• Sufficient German language skills to understand the study information and exercise instructions, report symptoms, and complete the study questionnaires
• Able to understand the study and provide written informed consent
• Able to take part in the supervised online exercise sessions, including access to an internet-enabled device and a sufficiently stable internet connection

You may not qualify if:

• An acute medical condition that makes physical exercise unsafe, as determined by the treating physician
• Cognitive or mental health problems that prevent safe participation in the exercise program or understanding of the study procedures
• Pregnancy or plans to become pregnant during the 12-week study intervention
• Insufficient German language skills to participate safely in the exercise program or to complete the study assessments
• Participation in another structured exercise or training program that could affect the study results. Normal daily activities and self-directed physical activity are allowed.

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

Study Sites (1)

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Study Officials

• Miriam Goette, PD Dr. rer. medic.

  University Hospital, Essen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Zimmer, M.Sc.

CONTACT

+49 201 723 7305; rebecca.zimmer@uk-essen.de

Miriam Götte, PD Dr. rer. medic.

CONTACT

+49 201 723 8083; miriam.goette@uk-essen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. rer. medic.

Study Record Dates

• First Submitted: September 30, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): July 1, 2030
• Last Updated: October 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)